MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN LTD. LARYSEAL CLEAR LARYNGEAL MASK AIRWAY SIZE 5; LARYNGEAL MASK AIRWAY (LMA)

Catalog Number 038-94-350U

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

User reported that unable to get an adequate seal and exchanged the device for another of the same size and lot number without further issue.No harm to patient.Device disposed of and therefore unavailable for return to manufacturer.Report noted that pilot balloon valve had failed.Lot number identified as 170501396 which identifies the manufacturing date as may 2017.There had been occasional reports of valve failure and the sub-supplier of the component part was changed to a new source in july 2018.There have been no reports any valve failures since this change.The ifu states that the inflation of the cuff is part of the pre-use checks to identify any possible leak before commencement of the procedure.

Event Description

Laryngeal mask airway (laryseal size 5) used on a patient but unable to effect a good seal.Device removed and replaced with the same product and lot number without an issue.

• Brand Name: LARYSEAL CLEAR LARYNGEAL MASK AIRWAY SIZE 5
• Type of Device: LARYNGEAL MASK AIRWAY (LMA)
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN LTD.; no. b-15 xicheng ind zone 1; hengli town; dongguan city, 52346 0; CH 523460
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN LTD.; no. b-15 xicheng ind zone 1; hengli town; dongguan city, 52346 0; CH 523460
• Manufacturer Contact: richard downs ; cynon valley business park; mountain ash, CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 9320478
• MDR Text Key: 199319230
• Report Number: 3006061749-2019-00012
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: 038-94-350U
• Device Lot Number: 170501396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1